International Biomedical has obtained a 510(k) regulatory clearance from the FDA for its Puffin Infant Resuscitator.

Almost 15% of all neonates are in need of respiratory support at birth, according to the company. For those affected newborns, the Puffin offers everything needed at their bedside: T-Piece or bag and mask ventilation, integrated suction which makes airway management less stressful and blended air/oxygen delivery along with monitored delivery of positive pressure breaths.

The portable and compact design of the Puffin can be used to enable respiratory support in all perinatal areas of the hospital: labor and delivery room, well baby nursery, neonatal intensive care and the emergency room. Puffin can be easily mounted to bedside warmers and incubators or placed at bedside on its optional mobile stand.

“Puffin was designed with feedback from our numerous neonatal customers and respiratory therapists who wanted a manually controlled respiratory support device, that includes all of the equipment you may need in any resuscitation situation,” said Greg Will, vice president of Sales and Marketing of International Biomedical.